RADIUS-HTN study is a prospective, multi-center, international, post-market, randomized (1:1) clinical trial in patients with uncontrolled hypertension. The objective is to compare the safety and efficacy of radio frequency renal denervation using the Iberis Renal Denervation System (AngioCare) via radial access compared with femoral access.
Study objectives
The study plans to enroll 90 patients with uncontrolled hypertension treated with 2 to 5 anti-hypertensive drugs and eligible for both TransFemoral Access and TransRadial Access. The patients will be followed at 3 and 6 months after procedure.
Primary endpoints
Change in office systolic blood pressure at 3 months.
CERC Services
- CEC activities
- Contract management
- EDC and data management
- Monitoring activities
- SAE Reporting
- Statistical Analysis
- Submission to competent authorities and ethic committees
Countries
3 countries in Europe: France, Germany and Switzerland.
Number of investigational sites
12
